Position Summary
The Equipment & Facilities Engineer is responsible for overseeing the maintenance, calibration, and operational readiness of equipment, utilities, and facilities supporting cGMP manufacturing and laboratory environments. This role ensures the efficient, reliable, and compliant operation of site infrastructure. The ideal candidate will bring strong engineering expertise, hands-on technical problem-solving skills, and the ability to collaborate cross-functionally in a regulated environment.

Key Responsibilities

Facility & Equipment Maintenance & Operations

• Manage and oversee maintenance and calibration of manufacturing equipment, utilities (e.g., HVAC, purified water systems, compressed air), and laboratory instruments in compliance with cGMP requirements.
• Provide engineering oversight for laboratory and manufacturing equipment, including new installations and troubleshooting activities.
• Ensure facilities meet industry standards, regulatory requirements, and Good Manufacturing Practices (GMP).
• Support and improve the preventive maintenance program to minimize downtime and extend asset lifecycle.
• Troubleshoot equipment and system issues to maintain operational efficiency.
• Coordinate with contractors and vendors for repairs, upgrades, and calibration services.
• Develop and maintain technical documentation including maintenance records, calibration logs, and validation documentation.
• Identify and implement continuous improvement initiatives to enhance operational performance.

Quality & Regulatory Compliance

• Coordinate commissioning, qualification, and validation (CQV) activities for equipment and facility systems.
• Ensure compliance with applicable regulations, including GMP, OSHA, and environmental requirements.
• Support internal and external audits and inspections.
• Maintain facility and equipment documentation aligned with regulatory expectations.

Project Management

• Partner with vendors, contractors, and internal stakeholders to manage capital projects and equipment installations.
• Support planning and execution of facility improvements and expansions.
• Coordinate upgrades to utilities, building systems, and equipment to support operational needs.

Energy & Resource Management

• Monitor facility energy usage and identify efficiency improvements.
• Support sustainability initiatives and waste management compliance.

Cross-Functional Collaboration

• Work closely with Manufacturing, Quality, and other departments to ensure facility systems meet operational requirements.
• Provide technical support for cleanrooms and controlled environments.
• Assist with training staff on equipment and facility systems.

Documentation & Reporting

• Maintain accurate maintenance and compliance records.
• Support EHS initiatives related to equipment and facilities.
• Prepare reports on system performance and facility metrics.
• Ensure documentation is inspection-ready at all times.

Qualifications

• Bachelor’s degree in Mechanical Engineering, Chemical Engineering, Electrical Engineering, or related technical field.
• At least 3 years of experience in facilities, equipment, or engineering support within a GMP-regulated environment (GMP experience is required).
• Experience supporting HVAC systems, cleanrooms, and pharmaceutical/biotech utilities preferred.
• Familiarity with commissioning, qualification, and validation activities.
• Knowledge of FDA, GMP, OSHA, and other applicable regulatory requirements.
• Strong troubleshooting and technical problem-solving skills.
• Ability to work in a fast-paced, cross-functional environment.
• Process engineering experience is a plus.

Additional Requirements

• Must be authorized to work in the United States without sponsorship now or in the future.
• Relocation assistance is not available for this position.